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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01139060
Other study ID # 5R01MH082995
Secondary ID
Status Completed
Phase Phase 3
First received June 4, 2010
Last updated October 11, 2017
Start date August 2009

Study information

Verified date October 2017
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- all patients will meet criteria for recurrent major depression or dysthymia

Exclusion Criteria:

- bipolar disorder or psychotic disorder

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
organized care program for chronic or recurrent depression


Locations

Country Name City State
United States Group Health Research Insitute Seattle Washington
United States Swedish Cherry Hill Clinic Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Kaiser Permanente Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors) 18 months
Secondary Examination of moderators of treatment response 18 months
Secondary An estimate of the program's costs and effect on the costs of treatment for depression 18 months
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